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Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings.

Hofmann, Nicola; Lafarge, Xavier; Antica, Mariastefania; Ferry, Nicolas; Girandon, Lenart; Gramignoli, Roberto; Jurga, Marcin; Kerdjoudj, Halima; Navakauskiene, Ruta; Schiavi, Jessica; Shabli, Volodymyr; Nicolás, Francisco J; Gindraux, Florelle (2023) Expert Consideration on Regulatory Aspects for Perinatal Derivatives in Clinical Settings.. Stem Cells Translational Medicine, 12 (5). pp. 258-265. ISSN 2157-6564

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Perinatal derivatives (PnD) are drawing growing interest among the scientific community as an unrestricted source of multipotent stem cells, secretome, and biological matrices. They are useful for the treatment of diseases that currently have limited or no effective therapeutic options, but they require the development of regenerative approaches. With this development, the question of regulation of donation, processing, and distribution has therefore become more important. Within the European Cooperation in Science and Technology (COST) community, we compiled a group of international experts on PnD technologies, who revised and compared existing EU national regulations. Notably, despite clear European directives, each EU Country has developed their own implementation and standard levels for cell- and tissue-based therapies. To enable extended applications of PnD treatments within the EU community and worldwide, harmonization is highly recommended. This paper aims to provide an overview of the various options available to introduce PnD into clinical practice. For this purpose, the different aspects resulting from (1) the type of PnD, (2) the amount of available data, (3) the degree of manipulation, and (4) the intended application and the process toward a possible commercialization will be presented. In the future, it will be important to find a balance between regulatory requirements and the best medical quality of the PnD product.

Item Type: Article
Uncontrolled Keywords: perinatal tissues; placenta; European regulation; cell therapy; ATMP
Subjects: BIOMEDICINE AND HEALTHCARE > Basic Medical Sciences > Cytology, Histology and Embryology
BIOMEDICINE AND HEALTHCARE > Basic Medical Sciences > Human Physiology
BIOMEDICINE AND HEALTHCARE > Basic Medical Sciences > Immunology
BIOMEDICINE AND HEALTHCARE > Clinical Medical Sciences
BIOTECHNICAL SCIENCES > Biotechnology > Biology
Divisions: Division of Molecular Biology
Project titleProject leaderProject codeProject type
Obnova timusa za preciznu medicinu u liječenju tumora i leukemija-THYMINNOVAMariastefania AnticaIP-2020-02-2431HRZZ
Znanstveni centar izvrsnosti za reproduktivnu i regenerativnu medicinu – istraživanja novih platormi i potencijala-CERRMSiniša Volarević; Slobodan Vukičević; Davor JežekKK.
International Network for Translating Research on Perinatal Derivatives into Therapeutic ApproachesOrnella ParoliniCA17116EK
Depositing User: Mariastefania Antica
Date Deposited: 19 Apr 2023 08:48
DOI: 10.1093/stcltm/szad017

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